CARDIO METRICS CARDIOTOMY RESERVOIR— 510(k) K841958

Name: FDA 510(k) clearance K841958
Creator: U.S. Food and Drug Administration
Published: 1984-10-15

Substantially Equivalent

Sterile Design, Inc.

FDA 510(k) clearance K841958 for CARDIO METRICS CARDIOTOMY RESERVOIR, Substantially Equivalent on 1984-10-15. Applicant: Sterile Design, Inc.. Device class: 2.

Clearance details

Applicant: Sterile Design, Inc.
Product code: Code JOD
Device class: Class 2
Regulation: 21 CFR 870.4270
Advisory panel: Cardiovascular
Date received: 1984-05-14
Decision date: 1984-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

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